Identity
- Trade Name
- Surgical Guide Resin EUDAMED
- Device Name
- Surgical Guide Resin EUDAMED
- Model / Reference
- BSM-SG04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932195326112 EUDAMED
- Basic UDI-DI
- 69321953MXSZ0202DK EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Surgical Guide Resin by Chengdu Besmile Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69321953MXSZ0202DK | Class I | Active |
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Manufacturer
- Manufacturer
- Chengdu Besmile Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025929
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 2eba9722-896b-4356-ac59-e03d773ea227 61 fields · synced Jun 19, 2026